The following data is part of a premarket notification filed by Cox-uphuff Intl. with the FDA for Cui Tissue Expander Versafil(tm) Tissue Expander.
| Device ID | K865056 |
| 510k Number | K865056 |
| Device Name: | CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER |
| Classification | Expander, Skin, Inflatable |
| Applicant | COX-UPHUFF INTL. P.O. BOX 40288 Santa Barbara, CA 93140 |
| Contact | David J Schuessler |
| Correspondent | David J Schuessler COX-UPHUFF INTL. P.O. BOX 40288 Santa Barbara, CA 93140 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-24 |
| Decision Date | 1987-05-22 |